Ziehm Vision R
Catalogue number Vision R, listed by Ziehm Imaging Gmbh, Germany, under Image-Intensified Fluoroscopic X-Ray System, Mobile. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Ziehm Imaging Gmbh, Germany |
|---|---|
| FDA product code | OXO |
| Device type | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Manufacturer |
| 510(k) | K061203 |
| Record published | 2016-09-23 |
| Record revised | 2025-03-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2025-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Vision R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O-ARM® | Medtronic Navigation, Inc. | 16 |
| Cios Select | Siemens Shanghai, Medical Equipment Ltd. | 3 |
| Smart-C | Turner Imaging Systems, Inc. | 3 |
| Zenition | Philips Medical Systems Nederland B.V. | 2 |
| Broach Set SPX1 | Ecential Robotics | 2 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | Ecotron Co., Ltd. | 2 |
| Flourocsan InSight | Hologic, Inc. | 2 |
| Genoray | Genoray Co., Ltd. | 2 |
| 3D Imaging Set SPX1 | Ecential Robotics | 2 |
| Discovery | GE Medical Systems, LLC | 2 |
| OEC | Ge Hualun Medical Systems Co., Ltd. | 2 |
| Cios Alpha | Siemens Healthcare Limited | 1 |
Showing 12 of 40. All products under Image-Intensified Fluoroscopic X-Ray System, Mobile
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Orthoscan, Inc. | 510(k) number | 2024-08-08 | Class II | Radiation Control for Health and Safety Act | Ziehm Imaging, Inc., distributor, have been informed by manufacturer, Ziehm Imaging GmbH that installed devices may not fully meet the requirements of IEC 60601-2-54 and or 21 CFR 1020.32(c) with respect to wired hand switch may fail when b | 5 | |
| Ziehm Imaging Gmbh | 510(k) number | 2016-04-15 | Class II | Device Design | Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted. | 1 device | 2019-07-18 |
| Ziehm Imaging Gmbh | 510(k) number | 2013-11-21 | Class II | Device Design | Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices. | 103 devices | 2014-06-23 |
| Ziehm Imaging Gmbh | 510(k) number | 2011-04-29 | Not classified | Component design/selection | On 04/29/2011, Ziehm Imaging, Inc., Orlando, FL recalled the double foot switch, type KF 2 1S/1S-MED-AP, a component used with Ziehm Imaging GmbH Mobile C-arm due to the potential of unintentional continued activation of fluoroscopic X-ray | 49 units | 2012-04-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.